Forge Biologics Announces the FUEL™ AAV Manufacturing Platform to Provide Developers with a More Efficient Solution for Gene Therapy Production

FUEL™ platform can achieve a 2-6x increase in productivity compared to industry standardNew innovative platform technologies include pEMBR 2.0™ Ad helper and modified rep/cap plasmidsData on FUEL™ platform will be presented at Cell & Gene Meeting on the Mesa

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced the launch of its FUEL™ manufacturing platform to provide AAV gene therapy developers a more efficient and accelerated foundation for manufacturing as they advance new programs and target a broader range of diseases.

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The FUEL™ (Foundation for Unleashing Excellence in Life-Changing Therapies) platform introduces several new technical advancements, including Forge’s pEMBR 2.0™ Ad helper plasmid which is one of the smallest commercially available at 8.9kb, offering an enhanced safety profile and increased manufacturing efficiency. The platform also features new modified rep/cap plasmids, whereby a client-specific capsid sequence is incorporated into Forge’s proprietary backbone plasmid. Forge’s trusted HEK293 suspension Ignition™ cell line remains a vital component of the platform. Together, these proprietary technologies, combined with Forge’s proven manufacturing processes and unique optimization packages provide a faster, potentially safer, and more efficient foundation for AAV production.

“As a CDMO, we prioritize continuous innovation to deliver effective solutions for our groundbreaking clients who are focused on advancing their programs from the discovery phase to first-in-human clinical trials and beyond,” said John Maslowski, President & CEO of Forge. “The FUEL™ platform represents years of extensive R&D on our innovative technologies and builds upon our well-established manufacturing processes with a deep understanding of the need for product-specific flexibility with numerous optimization packages.”

“I’m incredibly proud of our team’s exceptional collaboration that has brought us to this point with the FUEL™ platform and the productivity gains we’re seeing,” said David Dismuke, Ph.D., Chief Technical Officer of Forge. “From molecular development’s research for our new pEMBR 2.0™ Ad helper design, to our process development team’s repeatable high-titer manufacturing processes, Forge remains focused on driving manufacturing excellence for our clients and the industry as it continues to expand and reach broader patient populations.”

Forge will launch the FUEL™ platform and highlight its key benefits during a company presentation by Mr. Maslowski on October 8, 2024, at 3:15 p.m. during the Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa conference in Phoenix, Arizona. For more information, please visit https://meetingonthemesa.com/.

About Forge Biologics

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.

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